Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids (Halt)
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation|
- Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure [ Time Frame: 12 months from Baseline ] [ Designated as safety issue: No ]Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.
- Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).
- Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment [ Time Frame: 12 months from Baseline ] [ Designated as safety issue: No ]Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.
- Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging) [ Time Frame: 12 month from Baseline ] [ Designated as safety issue: No ]Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.
- Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool. [ Time Frame: 12 months from Baseline ] [ Designated as safety issue: No ]
The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life.
Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates "change" in symptoms, a negative number indicates a reduction in symptoms and therefore improvement.
Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates "change" in health and quality of life, a positive number indicates and improvement.
- Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.
- Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.
|Study Start Date:||March 2009|
|Study Completion Date:||March 2014|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Halt Procedure
In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
Device: Halt Procedure
The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.
In this single-arm study, subjects who have symptomatic uterine fibroids will have laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874029
|United States, Arizona|
|Women's Health Research|
|Phoenix, Arizona, United States, 85015|
|United States, California|
|USC Medical Center|
|Los Angeles, California, United States, 90033|
|Pasadena Premier Women's Health|
|Pasadena, California, United States, 91145|
|Reproductive Science Center|
|San Ramon, California, United States, 94583|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48034|
|United States, Missouri|
|St. Luke's Hospital|
|Chesterfield, Missouri, United States, 63017|
|United States, Nevada|
|Athena Gynecology Medical Group|
|Reno, Nevada, United States, 89509|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Hospital Universitario Esperanza|
|Guatemala City, Guatemala, 01010|
|Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Principal Investigator:||Mary Hinckley, MD||Reproductive Science Center|
|Principal Investigator:||Micah Harris, MD||Women's Health Research|
|Principal Investigator:||Erika Banks, MD||Montefiore Medical Center|
|Principal Investigator:||Karen R Abbott, MD||Athena Gynecology Medical Group|
|Principal Investigator:||Jay Berman, MD||Wayne State University|
|Principal Investigator:||Jose G Garza Leal, MD||Hospital Universitario Dr. Jose Eleuterio Gonzalez|
|Principal Investigator:||David Levine, MD||St. Johns' Mercy Medical Center|
|Principal Investigator:||Rodolfo Robles Pemueller, MD||Universidad Francisco Marroquin|
|Principal Investigator:||Jennifer Israel, MD||University of Southern California|
|Principal Investigator:||Richard S Guido, MD||Magee-Women's Hospital|
|Principal Investigator:||James Macer, MD||Pasadena Premier Women's Health|